Printed from Voxsanity (voxsanity.com.au) — NCT07590531 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Lung Cancer Trial, Recruiting
NCT07590531
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- People who are willing and able to give written consent to take part in the trial.
- People who are aged 18 to 75 years old at the time of screening.
- People who have been confirmed by tissue or cell testing to have locally advanced (Stage IIIB or IIIC) or metastatic (Stage IV) non-small cell lung cancer (NSCLC) that cannot be fully removed by surgery and cannot be treated with the aim of a cure using chemotherapy combined with or followed by radiation therapy.
- For the early stage of the trial (Stage Ib): people with locally advanced or metastatic NSCLC, whether or not they have previously received systemic cancer treatment.
- For the later stage of the trial (Phase II), people must fit into one of these groups: Cohort 1 — confirmed non-squamous NSCLC with no EGFR mutation and no ALK gene fusion; Cohort 2 — confirmed squamous-cell NSCLC with no EGFR mutation and no ALK gene fusion; or Cohort 3 — confirmed non-squamous NSCLC with an EGFR mutation present.
- People who have at least one measurable area of disease that can be tracked using standard imaging guidelines (RECIST 1.1).
- People with a general health and activity level rated as 0 or 1 on the ECOG scale, meaning they are fully active or able to carry out light work (confirm with trial site).
- People whose life expectancy is at least 12 weeks.
- People whose blood and other laboratory test results meet the trial's required levels (confirm with trial site for specific values).
- Women who could become pregnant must agree to use two effective forms of contraception during treatment and for at least 12 weeks after the last dose of the study drug.
- Women who could become pregnant must have a negative blood pregnancy test within seven days before receiving the first dose of the study drug.
- Male participants must agree to use a latex condom during treatment and for at least 12 weeks after the last dose, even if they have had a vasectomy.
- Male participants must agree not to donate sperm, and female participants must agree not to donate eggs, during treatment and for at least 12 weeks after the last dose.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People whose lung cancer has been identified as small cell lung cancer.
- People in Cohort 1 or Cohort 2 of Phase II who have NSCLC with certain known genetic changes, including EGFR-sensitive mutations, ALK fusions, BRAF V600E mutations, ROS1 fusions, MET exon 14 skipping mutations, NTRK fusions, or RET fusions.
- People who have previously been treated with any therapy targeting CD44v9, or with a type of drug called an antibody-drug conjugate (ADC) that uses a topoisomerase I inhibitor as its active component.
- People who have received any of the following treatments before starting the trial: systemic cancer treatments (such as chemotherapy or biologics) within 3 weeks before the first dose; hormonal cancer therapy or small-molecule targeted therapy within 2 weeks before the first dose; Chinese herbal medicines or preparations used for cancer within 2 weeks before the first dose; or immune-modifying treatments (such as interleukins, interferons, or similar) within 2 weeks before the first dose.
- People who have received a live or weakened (attenuated) vaccine within 4 weeks before the first dose.
- People who have had radiation therapy within 3 weeks before the first dose (though palliative radiation for symptom relief given at least 2 weeks before the first dose may be permitted — confirm with trial site).
- People who have received systemic immune-suppressing medications (such as corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, or anti-TNF drugs) within 2 weeks before the first dose.
- People who still have side effects from previous cancer treatment that have not settled back to a mild level (Grade 1 or lower).
- People who have had a serious immune-related side effect from previous treatment, including one that required the permanent stopping of that treatment, a severe (Grade 3 or higher) immune-related reaction, or any grade of immune-related heart, nerve, or eye problem (including Grade 2 immune-related lung inflammation, but not including Grade 3 underactive thyroid that is manageable with hormone replacement therapy).
- People with brain or central nervous system (CNS) spread of cancer that is causing symptoms, or that the treating doctor considers needs treatment but has not yet been treated (people with stable, symptom-free brain metastases that have been stable for at least 2 weeks, meet specific additional conditions, and have had no new or growing areas on imaging in at least 4 weeks may still be considered — confirm with trial site).
- People who have had another type of cancer in the 5 years before the first dose, other than the cancer they are being enrolled for.
- People who have had major surgery within 4 weeks before the first dose, have not fully recovered from surgery, have had a serious injury within 4 weeks before the first dose, or who are expected to need surgery during the trial or within 4 weeks after the last dose.
- People with a history of interstitial lung disease (scarring or inflammation of the lungs) or non-infectious lung inflammation that required steroid treatment; currently active lung disease of this type; suspected lung disease of this type; or other lung conditions that significantly affect lung function.
- People with a currently active autoimmune disease, or a history of autoimmune disease that required systemic treatment within the past 2 years.
- People with a current or past history of inflammatory bowel disease, such as Crohn's disease, ulcerative colitis, or long-term diarrhoea.
- People with a history of hypertensive crisis (a sudden, severe rise in blood pressure) or hypertensive encephalopathy (brain problems caused by very high blood pressure).
- People with severe blood clotting disorders or other signs of significant bleeding risk.
- People with uncontrolled fluid build-up around the lungs or in the abdomen that has needed repeated draining within 4 weeks before the first dose.
- People with an active infection being treated with systemic antibiotics or antimicrobials within 2 weeks before the first dose, or who have had a severe infection (such as sepsis or severe pneumonia requiring hospitalisation) within 4 weeks before the first dose.
- People with a history of internal fistulas (abnormal passages between organs), tracheoesophageal fistula, certain genital fistulas, bowel perforation, or abdominal abscess, or who the investigator considers to be at risk of bowel obstruction (those whose fistula or perforation has been fully treated by surgery and the investigator confirms the condition has completely resolved may still be considered — confirm with trial site).
- People with other poorly controlled health conditions, including but not limited to poorly controlled high blood pressure or diabetes, psychiatric disorders, or conditions that the investigator believes could affect how well the person can follow the study requirements or interfere with study procedures.
- People with a known disease affecting the immune system, or with HIV infection.
- People who test positive for hepatitis B surface antigen and/or hepatitis C antibodies at screening, unless further testing clearly shows there is no active hepatitis B or C infection requiring antiviral treatment (confirm with trial site for specific test thresholds).
- People with known active tuberculosis (TB), or suspected active TB that has not been ruled out by clinical assessment.
- People who have received a transplanted organ from another person, or a stem cell transplant from another person, except for corneal transplants.
- People with a known serious allergic reaction to the study drug or any of its ingredients, or a history of allergic reactions to similar treatments.
- Women who are pregnant (confirmed by a positive β-hCG test) or who are breastfeeding.
- People who are unwilling or unable to follow the trial procedures as set out in the protocol.
- People who need to take a strong CYP3A4 inhibitor (a type of medication that affects how certain drugs are broken down in the body) within one week before dosing or during the trial (confirm with trial site for a list of affected medications).
- People with any other disease, metabolic condition, physical finding, or laboratory result that the investigator believes may put the person at higher risk of complications, interfere with the safety assessment, or affect the interpretation of trial results.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
If this is close to home
This page includes language about advanced illness, prognosis, or palliative care, because that is how the trial's eligibility criteria are written. Seeing it set out plainly can land hard, whether it is about you or about someone you are caring for. You do not have to be at a crisis point to talk to someone.
- Griefline — grief and loss counselling, 9am to 6pm weekdays and midday to 6pm weekends (AEST/AEDT): 1300 845 745
- Carer Gateway — practical and emotional support if you are caring for someone, 8am to 5pm weekdays: 1800 422 737
- Canteen — for 12 to 25 year olds affected by cancer, their own or a family member's: 1800 945 215
- Palliative Care Australia — directory of palliative care services near you: palliativecare.org.au
- Lifeline — 24/7, for any kind of distress, at any hour the services above are closed: 13 11 14
Palliative care is not the same as giving up on treatment, and it is not only for the last weeks of life. It is symptom and comfort care that can run alongside active treatment, including a clinical trial.
Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of support and crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention.
Voxsanity is not a counselling or medical service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.
Contact this trial
Phone: 13917933915
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Status
Recruiting
Phase
Phase 2
Sponsor
Multitude Therapeutics Inc.
Registry
ClinicalTrials.gov
Start date
1 May 2026
Est. completion
30 May 2027
Where this trial is recruiting
🇨🇳 China
Primary endpoints
Phase I: To evaluate the safety and tolerability of the combination of AMT-116 and AK112 in patients with advanced NSCLC and to determine the recommended Phase 2 dose (RP2CD); Phase I: Type, incidence and severity of Adverse Events,Dose Limiting Toxicities (DLTs); Phase II: Objective Response Rate(ORR); Phase II: Type, incidence and severity of Adverse Events
Can't join this trial?
Data last synced from ClinicalTrials.gov: 13 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.